(90 days)
Not Found
No
The description focuses on basic visualization technology and does not mention any AI/ML features or image processing beyond real-time display.
No.
The intended use states the device is for "illumination and visualization" in diagnostic and operative procedures, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures".
No
The device description clearly outlines hardware components including a probe with an integrated camera, an LED light source, an LCD monitor, and connecting cables. It is a physical device with software controlling its functions, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Camera Enabled Probe is used for direct visualization of the interior of the body during surgical or diagnostic procedures. It provides real-time video of the internal anatomy.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool for direct observation.
The device falls under the category of endoscopic or arthroscopic visualization systems, which are medical devices used for imaging inside the body, but they are not considered IVDs.
N/A
Intended Use / Indications for Use
The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Product codes
HRX
Device Description
The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the illumination and imaging optics. The Camera Enabled Probes are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor is 220mm X 135mm X 39mm. The entire unit weight is less than 300 grams.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify that device design meets its functional and performance requirements, representative samples of the device underwent biocompatibility, software, electrical, and mechanical testing in accordance with the following industry standards.
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
IEC-60601-1 > Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
EN-60601-1-2 > Medical Electrical Equipment. General Requirements for Basic Safety and Essential Performance. Collateral Standard. Electromagnetic Compatibility. Requirements and Tests
ISO-11135-1 > Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ISO-9626 > Stainless Steel Needle Tubing for the Manufacture of Medical Devices
ISO-7864 > Sterile Hypodermic Needles for Single Use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
JUL 2 9 2014
2.0 510(k) Summary
| Table 1: 510(k) Summary | |
|---|---|
| Submitter: | Trice Medical, Inc. |
| 1000 Continental Drive, Suite 240 | |
| King of Prussia, PA 19406 | |
| Contact Person: | Tiffini Diage |
| Consulting Director Regulatory Affairs | |
| Phone: 707.799.6732 | |
| E-mail: tdiage@raechelon.com | |
| Date Prepared: · | 4/29/14 |
| Trade Name: | Camera Enabled Probe |
| Common Name: | Arthroscope |
| Classification: | Class II |
| Product Code: | HRX, 888.1100 |
| Predicate Device(s): | The subject device is equivalent to the following devices: |
| • K093717 - C-MOR Visualization System | |
| Device Description: | The Camera Enabled Probe is a battery operated, portable, |
| visualization device that uses a probe with integrated camera | |
| and separate LCD monitor attached via cable. The sterile, | |
| single-use probe includes the camera and image capture | |
| features with LED light source. The LCD Monitor displays real- | |
| time video from the probe and is attached via cable to provide | |
| power to the probe. The probe scope extends from the handle | |
| as a rigid shaft with retractable needle and flushing port for | |
| cleaning the field of view. The distal tip of the probe contains | |
| the illumination and imaging optics. | |
| The Camera Enabled Probes are identical in design and function | |
| and available in three lengths: 50mm, 95mm, and 160mm. The | |
| monitor is 220mm X 135mm X 39mm. The entire unit weight is | |
| less than 300 grams. | |
| Indication for Use: | The Camera Enabled Probe is indicated for use in diagnostic and |
| operative arthroscopic and endoscopic procedures to provide | |
| illumination and visualization of an interior cavity of the body | |
| through either a natural or surgical opening. |
Trice Medical, Inc.
Premarket Notification for the Camera Enabled Probe
1
| Functional and
Safety Testing: | To verify that device design meets its functional and
performance requirements, representative samples of the
device underwent biocompatibility, software, electrical, and
mechanical testing in accordance with the following industry
standards. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 10993-1:2009 Biological evaluation of medical devices - Part
1: Evaluation and testing within a risk management process |
| | IEC-60601-1 > Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential Performance |
| | EN-60601-1-2 > Medical Electrical Equipment. General
Requirements for Basic Safety and Essential Performance.
Collateral Standard. Electromagnetic Compatibility.
Requirements and Tests |
| | ISO-11135-1 > Sterilization of Health Care Products. Ethylene
Oxide. Requirements for Development, Validation and Routine
Control of a Sterilization Process for Medical Devices |
| | ISO-9626 > Stainless Steel Needle Tubing for the Manufacture of
Medical Devices |
| | ISO-7864 > Sterile Hypodermic Needles for Single Use |
| Conclusion: | Trice considers the Camera Enabled Probe device to be
equivalent to the predicate device listed above. This conclusion
is based upon the devices' similarities in indications for use,
principles of operation, technology, and materials. |
Trice Medical, Inc.
Page 2 of 2
Premarket Notification for the Camera Enabled Probe
2
Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2014
Trice Medical Incorporated Ms. Tiffini Diage Consulting Director Regulatory Affairs 1000 Continental Drive, Suite 240 King of Prussia, Pennsylvania 19406
Re: K141119
Trade/Device Name: Camera Enabled Probe Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class; Class II Product Code: HRX Dated: July 17, 2014 Received: July 18, 2014
Dear Ms. Diage:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Tiffini Diage
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDeviccs/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
KI4119
Device Name Camera Enabled Probe
Indications for Use (Describe)
The Camera Enabled Probe is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the a natural or surgical opening.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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